Safety and Efficacy of Aliskiren on the Progression of Atherosclerosis in Coronary Artery Disease Patients (AQUARIUS)

This study is currently recruiting participants.

Verified December 2012 by Novartis

Sponsor:

Collaborator:

The Cleveland Clinic

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT00853827

First received: February 26, 2009

Last updated: December 13, 2012

Last verified: December 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 26, 2009

Last Updated Date

December 13, 2012

Start Date ^ICMJE

March 2009

Estimated Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in the progression of coronary atherosclerosis (defined as change from baseline in percent atheroma volume) as assessed by IVUS [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00853827 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change in normalized total atheroma volume as assessed by IVUS [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
Proportion of patients that demonstrate evidence of atheroma regression (defined as any reduction in percent atheroma volume from baseline) as assessed by IVUS [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
Overall safety and tolerability of aliskiren compared to placebo following treatment duration [ Time Frame: 104 weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Safety and Efficacy of Aliskiren on the Progression of Atherosclerosis in Coronary Artery Disease Patients

Official Title ^ICMJE

A 104 Week, Randomized, Double Blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy of Aliskiren on the Progression of Atherosclerosis in Patients With Coronary Artery Disease When Added to Optimal Background Therapy

Brief Summary

The study will assess the change in coronary atherosclerotic disease as determined by intravascular ultrasound (IVUS) for aliskiren compared to placebo when given in addition to standard therapy in patients with coronary artery disease (CAD) and a blood pressure in the pre-hypertensive range.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Coronary Artery Disease (CAD)
Coronary Atherosclerosis

Intervention ^ICMJE

Drug: Placebo
Placebo
Drug: Aliskiren
300 mg

Study Arm (s)

Placebo Comparator: 1
Intervention: Drug: Placebo
Experimental: 2
Aliskiren 300 mg

Intervention: Drug: Aliskiren

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

592

Estimated Completion Date

January 2013

Estimated Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients with CAD who have blood pressure in the pre-hypertensive range defined as a msSBP ≥ 125 and ≤ 139mmHg and a msDBP < 90mmHg.
Patients with or without current treatment for hypertension
Angiographic evidence of coronary artery disease
At least 2 qualifying Cardiovascular risk factors at Visit 1

Exclusion Criteria:

Baseline IVUS determined unacceptable
Patients requiring treatment with disallowed study medications
Patients with clinically significant heart disease
Previous or current diagnosis of heart failure (NYHA Class IV) or a documented left ventricular ejection fraction of < 25%
Patients requiring treatment with any 2 of the following classes of medication at Visit 1 or Visit 2:
- Angiotensin converting enzyme inhibitors
- Angiotensin receptor blockers
- aldosterone receptor blockers or a direct renin inhibitor.
Other conditions may apply

Gender

Both

Ages

35 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Novartis Pharmaceuticals

+1(862)778-8300

Location Countries ^ICMJE

United States, Argentina, Australia, Belgium, Canada, France, Germany, Hungary, Italy, Poland, Spain

Administrative Information

NCT Number ^ICMJE

NCT00853827

Other Study ID Numbers ^ICMJE

CSPP100A2366, 2008-006447-40

Has Data Monitoring Committee

Responsible Party

Novartis ( Novartis Pharmaceuticals )

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

The Cleveland Clinic

Investigators ^ICMJE

Study Director:	Novartis Pharmaceuticals	Novartis Pharmaceuticals
Study Director:	Novartis	Novartis

Information Provided By

Novartis

Verification Date

December 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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